Nova has identified quality issues affecting specified lots of StatStrip ketone test strips. The affected lots have been associated with quality-control (QC) failures and Nova has initiated a recall, advising that these lots should not be used. Lot numbers can be found on Nova’s Field Safety Notice. Nova has paused distribution of affected lots and advised that any further lots found to fail QC testing should also be withdrawn from use. This may result in further disruption to blood ketone point-of-care testing. Nova currently expects new product to be available for shipment to the UK during the week of 26 October 2026.

This National Patient Safety Alert provides further background, clinical information and actions for providers.